The Actor registration is the first of the six EUDAMED modules.
The Commission is not in a position to require the use of the Actor registration module until the transition periods laid down in Regulation (EU) 2024/1860 expire. Additional national requirements on registrations can therefore not be excluded.
Actor identifier / Single registration number (SRN)
The Actor registration module enables economic operators to submit, by means of an actor registration request, the information necessary to obtain an actor identifier/single registration number (Actor ID/SRN).
The Actor ID/SRN is a EU-wide unique identification for economic operators in the medical devices sector.
- Following the assessment and approval of the request by the concerned national competent authority, EUDAMED generates the Actor ID/SRN of the economic operator to the national competent authority and transfers it to the requesting economic operator
- Infographic: Actor roles and Actor ID/SRN
Actor registration request process
Economic operators in the medical devices sector Every economic operator (EU and non-EU manufacturers, authorised representatives, system/procedure pack producers and importers) must register as an actor in EUDAMED before placing devices or Systems/Procedure Packs in the EU market.
- Infographic: Actor registration request process
Documents to provide with the actor registration request
- Declaration on information security responsibilities
All actors must upload a signed declaration on information security responsibilities (template in all EU languages) - Mandate summary document
To register in EUDAMED, non-EU manufacturers must have an active authorised representative and submit a mandate summary document with their registration request.
EUDAMED registered users
When an actor is registered in EUDAMED, everyone who intends to act on behalf of this actor needs to submit an access request.
- Infographic: Users access requests
Documentation
- The EUDAMED Information Centre contains the relevant updated documentation including User Guides, technical documentation and Q&A sections.
Guidance
- MDCG 2021-13 Rev. 1 - Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR
- Guidance documents to assist stakeholders in implementing the medical devices regulations
